Electromagnetically driven blood pump

ABSTRACT

Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that may include a magnetic drive system of a blood pump. The magnetic drive system may include a drive shaft coupled to an impeller, a driven magnet assembly coupled to at least one of the drive shaft and the impeller, and a driving coil assembly configured to drive the driven magnet assembly.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of and claims priority to U.S. patentapplication Ser. No. 17/137,185, filed Dec. 29, 2020, which claimspriority to U.S. Provisional Application No. 62/964,102, filed Jan. 21,2020, which is herein incorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure relates to percutaneous circulatory supportdevices. More specifically, the disclosure relates to motors andbearings using in percutaneous circulatory support devices.

BACKGROUND

Percutaneous circulatory support devices such as blood pumps typicallyare easier to implant and provide greater benefit if they are made to beas small as possible, without sacrificing functionality. Typically, amotor housed in a motor housing drives an impeller that is housed in aseparate impeller housing.

SUMMARY

In Example 1, a magnetic drive system of a blood pump, the magneticdrive system includes a drive shaft coupled to an impeller andconfigured to rotate with the impeller; a driven magnet assembly coupledto at least one of the drive shaft and the impeller; and a driving coilassembly surrounding the driven magnet assembly and configured to drivethe driven magnet assembly.

In Example 2, the magnetic drive system of Example 1 the driven magnetassembly is coupled to the drive shaft proximal the impeller.

In Example 3, the magnetic drive system of either of Example 1 or 2, thedriving coil assembly includes a coil housing and a plurality of coilwindings disposed within the coil housing.

In Example 4, the magnetic drive system of Example 3, the coil housingis disposed within a pump housing and surrounds the driven magnetassembly.

In Example 5, the magnetic drive system of any of Examples 1-4, thedriven magnet assembly includes a permanent magnet disposed within amagnet cover.

In Example 6, a blood pump includes a pump housing; an impeller disposedwithin the pump housing; a drive shaft disposed within the pump housing,coupled to the impeller and configured to rotate with the impeller; adriven magnet assembly disposed within the pump housing and coupled toat least one of the drive shaft and the impeller; and a driving coilassembly disposed within the pump housing and surrounding the drivenmagnet assembly, and configured to drive the driven magnet assembly.

In Example 7, the blood pump of Example 6, the driven magnet assembly iscoupled to the drive shaft proximal the impeller.

In Example 8, the blood pump of either of Example 6 or 7, the drivingcoil assembly includes a coil housing and a plurality of coil windingsdisposed within the coil housing, the coil housing is disposed withinthe pump housing and surrounds the driven magnet assembly.

In Example 9, the blood pump of any of Examples 6-8, the driven magnetassembly includes a permanent magnet disposed within a magnet cover.

In Example 10, the blood pump of any of Example 6-9, further includes aproximal bearing assembly, a proximal end of the drive shaft isrotatably retained by the proximal bearing assembly.

In Example 11, the blood pump of Example 10, the proximal bearingassembly includes a first bearing portion including a distal-facingbearing surface having a depression defined therein; and a secondbearing portion including a proximal-facing bearing surface, the firstand second bearing portions are configured to be coupled together tocreate a chamber configured to retain the proximal end of the driveshaft.

In Example 12, the blood pump of Example 10, the proximal bearingassembly includes a first bearing portion including a distal-facingbearing surface; a second bearing portion including a proximal-facingbearing surface; and a third bearing portion including a radially-facingbearing surface, the first, second, and third bearing portions areconfigured to be coupled together to create a chamber configured toretain the proximal end of the drive shaft.

In Example 13, the blood pump of either of Example 11 or 12, the firstand second bearing portions are configured to be press-fit together,adhered together, or fastened together.

In Example 14, the blood pump of any of Examples 10-13, the firstbearing portion having a first aperture defined therethrough, the secondbearing portion having a second aperture defined therethrough, the firstand second apertures are configured to be aligned when the first andsecond bearing portions are coupled such that an electrical conductormay be disposed through the first and second apertures, the electricalconductor electrically couples a power source to the driving coilassembly.

In Example 15, the blood pump of any of Examples 10-14, the distal endof the drive shaft is not retained by a distal bearing assembly.

In Example 16, a magnetic drive system of a blood pump, the magneticdrive system includes a drive shaft coupled to an impeller andconfigured to rotate with the impeller; a driven magnet assembly coupledto at least one of the drive shaft and the impeller; and a driving coilassembly electrically coupled to a power source, surrounding the drivenmagnet assembly, and configured to drive the driven magnet assembly.

In Example 17, the magnetic drive system of Example 16, the drivenmagnet assembly is coupled to the drive shaft proximal the impeller.

In Example 18, the magnetic drive system of Example 16, the driving coilassembly including a coil housing and a plurality of coil windingsdisposed within the coil housing.

In Example 19, the magnetic drive system of Example 18, the coil housingis disposed within a pump housing and surrounds the driven magnetassembly.

In Example 20, the magnetic drive system of Example 16, the drivenmagnet assembly comprises a permanent magnet disposed within a magnetcover.

In Example 21, a blood pump, includes a pump housing; an impellerdisposed within the pump housing; a drive shaft disposed within the pumphousing, coupled to the impeller and configured to rotate with theimpeller; a driven magnet assembly disposed within the pump housing andcoupled to at least one of the drive shaft and the impeller; and adriving coil assembly disposed within the pump housing, electricallycoupled to a power source, surrounding the driven magnet assembly, andconfigured to drive the driven magnet assembly.

In Example 22, the blood pump of Example 21, the driven magnet assemblyis coupled to the drive shaft proximal the impeller.

In Example 23, the blood pump of Example 21, the driving coil assemblyincludes a coil housing and a plurality of coil windings disposed withinthe coil housing, the coil housing is disposed within the pump housingand surrounds the driven magnet assembly.

In Example 24, the blood pump of Example 21, the driven magnet assemblyincludes a permanent magnet disposed within a magnet cover.

In Example 25, the blood pump of Example 21, further includes a proximalbearing assembly, a proximal end of the drive shaft is rotatablyretained by the proximal bearing assembly.

In Example 26, the blood pump of Example 25, the proximal bearingassembly includes a first bearing portion including a distal-facingbearing surface having a depression defined therein; and a secondbearing portion including a proximal-facing bearing surface, the firstand second bearing portions are configured to be coupled together tocreate a chamber configured to retain the proximal end of the driveshaft.

In Example 27, the blood pump of Example 25, the proximal bearingassembly includes a first bearing portion including a distal-facingbearing surface; a second bearing portion including a proximal-facingbearing surface; and a third bearing portion including a radially-facingbearing surface, the first, second, and third bearing portions areconfigured to be coupled together to create a chamber configured toretain the proximal end of the drive shaft.

In Example 28, the blood pump of Example 27, the first and secondbearing portions are configured to be press-fit together, adheredtogether, or fastened together.

In Example 29, the blood pump of Example 27, the first bearing portionhaving a first aperture defined therethrough, the second bearing portionhaving a second aperture defined therethrough, the first and secondapertures are configured to be aligned when the first and second bearingportions are coupled such that an electrical conductor may be disposedthrough the first and second apertures, the electrical conductorelectrically couples a power source to the driving coil assembly.

In Example 30, the blood pump of Example 25, the distal end of the driveshaft is not retained by a distal bearing assembly.

In Example 31, a blood pump, includes a pump housing; an impellerdisposed within the pump housing; a drive shaft disposed within the pumphousing, coupled to the impeller and configured to rotate with theimpeller; a driven magnet assembly disposed within the pump housing andcoupled to at least one of the drive shaft and the impeller; a drivingcoil assembly disposed within the pump housing, electrically coupled toa motor, surrounding the driven magnet assembly, and configured to drivethe driven magnet assembly; and a proximal bearing assembly, a proximalend of the drive shaft is rotatably retained by the proximal bearingassembly, the proximal bearing assembly includes a first bearing portionincluding a distal-facing bearing surface; and a second bearing portionincluding a proximal-facing bearing surface, the first and secondbearing portions are configured to be coupled together to create achamber configured to retain the proximal end of the drive shaft.

In Example 32, the blood pump of Example 31, the driven magnet assemblyis coupled to the drive shaft proximal the impeller.

In Example 33, the blood pump of Example 31, the driving coil assemblyincludes a coil housing and a plurality of coil windings disposed withinthe coil housing.

In Example 34, the blood pump of Example 33, the coil housing isdisposed within the pump housing and surrounds the driven magnetassembly.

In Example 35, the blood pump of Example 34, the driven magnet assemblycomprises a permanent magnet disposed within a magnet cover.

While multiple embodiments are disclosed, still other embodiments of thepresently disclosed subject matter will become apparent to those skilledin the art from the following detailed description, which shows anddescribes illustrative embodiments of the disclosed subject matter.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a cross-sectional side view of a portion of anillustrative percutaneous mechanical circulatory support device (alsoreferred to herein, interchangeably, as a “blood pump”), in accordancewith embodiments of the subject matter disclosed herein.

FIG. 2A is a perspective view of a proximal bearing assembly retaining adrive shaft, in accordance with embodiments of the subject matterdisclosed herein.

FIG. 2B is a side view of the proximal bearing assembly and drive shaftof FIG. 2A, in accordance with embodiments of the subject matterdisclosed herein.

FIG. 2C is a cross-sectional side view, taken along the line A-A, of theproximal bearing assembly and drive shaft depicted in FIGS. 2A and 2B,in accordance with embodiments of the subject matter disclosed herein.

FIG. 3 depicts a cross-sectional side view of a portion of anotherillustrative percutaneous mechanical circulatory support device, inaccordance with embodiments of the subject matter disclosed herein.

While the disclosed subject matter is amenable to various modificationsand alternative forms, specific embodiments have been shown by way ofexample in the drawings and are described in detail below. Theintention, however, is not to limit the subject matter disclosed hereinto the particular embodiments described. On the contrary, the disclosureis intended to cover all modifications, equivalents, and alternativesfalling within the scope of the subject matter disclosed herein, and asdefined by the appended claims.

DETAILED DESCRIPTION

Embodiments of the subject matter disclosed herein include blood pumpand bearing designs that may facilitate reduction of the size of theform factor of mechanical circulatory assist devices by providing acompact electromagnetic driving system. In embodiments, metallic coilsare implanted into a sealed housing. An electronic controller alternatesthe current of the coils to alter the polarity of the electromagneticfield to drive a permanent magnet coupled to an impeller. The permanentmagnet is a strong magnet that may be encapsulated in a housing of somesort to eliminate risk of corrosion of the magnet or the need to coatthe magnet. The rotary motion of the magnet drives impeller rotation toprovide forward flow of blood and supply arterial blood pressure toensure organs are perfused sufficiently in patients. The permanentmagnet is bonded to a drive shaft. The drive shaft is placed in abearing fitting in which the proximal end of the shaft is retainedwithin a cavity defined in the proximal bearing assembly. This enablesthe shaft to rotate at speeds required to pump blood while maintainingthe shaft and impeller concentric within the housing to maintain aconsistent blade to tip gap. The fitting of the bearings is tightlycontrolled to an ID/OD tolerance between shaft and bearing such that thedegrees of freedom are minimized to get a good bearing fit and keepblood out of the bearings, reducing the risk of hemolysis andthrombosis.

The forward flow of the blood over the coil housing acts as a means todissipate heat from the electromagnetic coils. Given that air is a poorconductor of heat and can lead to heat buildup in the coil housing,which may limit motor performance if not addressed, steps may be takento reduce the thermal resistance from the electromagnetic coil to theexterior of the housing by minimizing the amount of air in the coilhousing. For example, the assembly of the coil within the housing mayalso be optimized for heat transfer by tolerancing assembly features tominimize the introduction of air gaps between components. The coil mayalso be coated through atomic layer deposition of a ceramic to enable atight assembly within the housing that minimizes gap between assembledcomponents to optimize heat transfer without creating the risk of anelectrical short circuit. In addition, the coil housing may have anon-electrolytic, high thermal conductivity liquid to increase heattransfer from the electromagnetic coil to the exterior of the coilhousing. The optimization of heat transfer to drive heat away from theelectromagnet coils can increase the torque output for an equivalentform factor device, or reduce the size of coil required, which mayfacilitate easier deliverability of the device and optimal positioning.Also, by eliminating a separate motor housing and motor in favor of acoil that in turn drives the magnet of the impeller, the length requiredto house such components may be greatly reduced from existing devices.

FIG. 1 depicts a cross-sectional side view of a portion of anillustrative percutaneous mechanical circulatory support device 100(also referred to herein, interchangeably, as a “blood pump”), inaccordance with embodiments of the subject matter disclosed herein. Asshown in FIG. 1 , the circulatory support device 100 includes a magneticdrive system 102 disposed within a pump housing 104. The magnetic drivesystem 102 is configured to drive an impeller 106 to provide a flow ofblood through the device 100. The impeller 106 is disposed within thepump housing 104, which includes a number of outlet apertures 108defined therein.

As shown in FIG. 1 , the magnetic drive system 102 includes a driveshaft 110 coupled to the impeller 106 and configured to rotate with theimpeller 106. As shown, the drive shaft 110 is at least partiallydisposed within the impeller 106. In embodiments, the drive shaft 110may be made of any number of different rigid materials such as, forexample, steel, titanium alloys, cobalt chromium alloys, nitinol,high-strength ceramics, and/or the like. A driven magnet assembly 112 iscoupled to at least one of the drive shaft 110 and the impeller 106. Inembodiments, for example, the driven magnet assembly 112 may be coupledto the drive shaft 110 proximal the impeller 106. In other embodiments,the driven magnet assembly 112 may be coupled directly to the impeller106, while, in some embodiments, the driven magnet assembly 112 may becoupled to the drive shaft 110 and the impeller 106. The magnetic drivesystem 102 includes a driving coil assembly 114 electrically coupled toa power source (not shown). The magnetic driving coil assembly 114surrounds the driven magnet assembly 112 and is configured to drive thedriven magnet assembly 112.

The driving coil assembly 114 includes a coil housing 116 and a numberof coil windings 118A disposed within the coil housing 116. Theelectromagnetic field could be generated from copper, graphene, or otherhigh thermal conductivity materials in coiled configurations. Thedriving coil assembly 114 may include any number of coil windings 118Aarranged in any number of configurations within the coil housing 116. Inembodiments, the coil housing 116 may actually include multiple,separate housings. The coil housing 116 is disposed within the pumphousing 104 and may circumferentially or longitudinally surround thedriven magnet assembly 112. As shown, in embodiments, the driven magnetassembly 112 may include a permanent magnet 140 disposed within a magnetcover 142, which may be hermetically sealed.

A controller (not shown) is operably coupled, via electrical conductors1188 to the driving coil assembly 114 and is configured to control thedriving coil assembly 114. The controller may be disposed within thepump housing 104 in embodiments, or, in other embodiments, may bedisposed outside the housing 104 (e.g., in a catheter handle,independent housing, etc.). In embodiments, the controller may includemultiple components, one or more of which may be disposed within thehousing 104. According to embodiments, the controller may be, include,or be included in one or more Field Programmable Gate Arrays (FPGAs),one or more Programmable Logic Devices (PLDs), one or more Complex PLDs(CPLDs), one or more custom Application Specific Integrated Circuits(ASICs), one or more dedicated processors (e.g., microprocessors), oneor more central processing units (CPUs), software, hardware, firmware,or any combination of these and/or other components. Although thecontroller is referred to herein in the singular, the controller may beimplemented in multiple instances, distributed across multiple computingdevices, instantiated within multiple virtual machines, and/or the like.

As shown, the impeller 106 is maintained in its orientation by the driveshaft 110, which is retained at a proximal end 120 by a proximal bearingassembly 122 and at a distal end 124 by a distal bearing assembly 126.According to embodiments, the proximal bearing assembly 122 and thedistal bearing assembly 126 may include different types of bearings.According to embodiments, the proximal bearing assembly 122 and/or thedistal bearing assembly 126 may include lubrication, while in otherembodiments, one and/or the other may not include lubrication. Inembodiments and as shown in FIG. 3 , the drive shaft 110 may be heldrigidly enough by the proximal bearing assembly 122 that a distalbearing assembly is not needed, in which case the drive shaft 110 is notheld in place by a distal bearing assembly.

As shown in FIG. 1 , the proximal bearing assembly 122 may include afirst bearing portion 128 and a second bearing portion 130, configuredto be coupled together to form a chamber 132 that is configured toretain the proximal end 120 of the drive shaft 110. According toembodiments, the first and second bearing portions 128 and 130 may beconfigured to be press-fit together, coupled using interlocking grooves,coupled using an adhesive, coupled using pins, coupled using fasteners,and/or the like. In embodiments, apertures 134 are defined through theproximal bearing assembly 122. The conductors 118B pass through theapertures 134 to electrically connect the coil windings 118A with thepower source. The proximal bearing assembly 122 may be configured toseal the catheter 136 from the blood.

The illustrative circulatory support device 100 shown in FIG. 1 is notintended to suggest any limitation as to the scope of use orfunctionality of embodiments of the present disclosure. The illustrativecirculatory support device 100 also should not be interpreted as havingany dependency or requirement related to any single component orcombination of components illustrated therein. Additionally, variouscomponents depicted in FIG. 1 may be, in embodiments, integrated withvarious ones of the other components depicted therein (and/or componentsnot illustrated), all of which are considered to be within the ambit ofthe present disclosure.

As described above, with regard to FIG. 1 , embodiments of the bloodpump include a proximal bearing assembly configured to maintain thedrive shaft in position and to seal the catheter from the blood, whileallowing electrical conductors to pass through to the coil windings. Inembodiments, a proximal bearing assembly may include three or morebearing portions. For example, FIG. 2A is a perspective view of aproximal bearing assembly 200 retaining a drive shaft 202, in accordancewith embodiments of the subject matter disclosed herein; FIG. 2B is aside view of the proximal bearing assembly 200 and drive shaft 202 ofFIG. 2A, in accordance with embodiments of the subject matter disclosedherein; and FIG. 2C is a cross-sectional side view, taken along the lineA-A, of the proximal bearing assembly 200 and drive shaft 202 depictedin FIGS. 2A and 2B, in accordance with embodiments of the subject matterdisclosed herein. According to embodiments, the circulatory supportdevice, and/or any number of various components thereof, may be the sameas, or similar to, corresponding components of the circulatory supportdevice 100 depicted in FIG. 1 .

As shown in FIGS. 2A-2C, the proximal bearing assembly 200 may include afirst bearing portion 204 comprising a distal-facing bearing surface206, a second bearing portion 208 comprising a proximal-facing bearingsurface 210, and a third bearing portion 212 having a radially-facingbearing surface 214. As shown, the first, second, and third bearingportions 204, 208, and 212 are configured to be coupled together, withthe third bearing portion 212 disposed between the first and the secondbearing portions 204 and 208. When coupled together, the bearingportions 204, 208, and 212 form a cavity 216 configured to retain aproximal end 218 of the drive shaft 202. As shown, for example, theproximal end 218 of the drive shaft 202 may be formed as a disc,configured to fit in the cavity 216 within the bearing assembly 200. Inembodiments, such as shown in FIG. 1 , the proximal end 218 of the driveshaft 202 may include a ball or other at least partially rounded shape,configured to be retained within the cavity 216. The head of the driveshaft 202 may contain internal grooves to create pressure as the headrotates, reducing friction and torque required to operate the pump.

The bearing portions 204, 208, and 212 may be coupled together using anynumber of different coupling techniques and/or mechanisms. For example,in embodiments, the bearing portions 204, 208, and 212 may be press-fitand secured with one or more pins 220, as shown in FIGS. 2A-2C. Inembodiments, the bearing portions 204, 208, and 212 may be adheredtogether using an adhesive, fastened together using one or morefasteners, and/or the like. The proximal bearing assembly may beattached to the impeller housing via laser welding, solder reflow, oradhesive application, and/or the like.

Further, in embodiments, apertures may be provided through the proximalbearing assembly 200 to facilitate connecting the coil windings with thepower source. For example, the first bearing portion 204 may include afirst aperture 222 defined therethrough, the second bearing portion 208may include a second aperture 224 defined therethrough, and the thirdbearing portion 212 may include a third aperture 226 definedtherethrough, such that the first, second, and third apertures 222, 224,and 226 are configured to be aligned when the first and second bearingportions 204 and 208 are coupled such that an electrical conductor maybe disposed through the apertures 222, 224, and 226, wherein theelectrical conductor electrically couples a power source to the drivingcoil assembly. In embodiments, the proximal bearing assembly may includeonly two bearing portions, in which case, each bearing portion mayinclude one or more apertures corresponding to one or more apertures inthe other bearing portion.

The illustrative proximal bearing assembly 200 and drive shaft 202 shownin FIGS. 2A-2C are not intended to suggest any limitation as to thescope of use or functionality of embodiments of the present disclosure.The illustrative proximal bearing assembly 200 and drive shaft 202 alsoshould not be interpreted as having any dependency or requirementrelated to any single component or combination of components illustratedtherein. Additionally, various components depicted in FIGS. 2A-2C maybe, in embodiments, integrated with various ones of the other componentsdepicted therein (and/or components not illustrated), all of which areconsidered to be within the ambit of the present disclosure.

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the presentdisclosure. For example, while the embodiments described above refer toparticular features, the scope of this disclosure also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the present disclosure is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

We claim:
 1. A blood pump, comprising: a drive shaft coupled to animpeller and configured to rotate with the impeller; a pump housing; animpeller disposed within the pump housing; a drive shaft disposed withinthe pump housing, coupled to the impeller and configured to rotate withthe impeller; a driven magnet assembly disposed within the pump housingand coupled to at least one of the drive shaft and the impeller; adriving coil assembly disposed within the pump housing, electricallycoupled to a power source, surrounding the driven magnet assembly andnot surrounding the impeller, and configured to drive the driven magnetassembly; a proximal bearing assembly, wherein a proximal end of thedrive shaft is rotatably retained by the proximal bearing assembly, theproximal bearing assembly comprising: a first bearing portion comprisinga distal-facing bearing surface having a depression defined therein; anda second bearing portion comprising a proximal-facing bearing surface,wherein the first and second bearing portions are configured to becoupled together to create a chamber configured to retain the proximalend of the drive shaft.
 2. The blood pump of claim 1, wherein the drivenmagnet assembly is coupled to the drive shaft proximal the impeller. 3.The blood pump of claim 1, wherein the driving coil assembly comprises acoil housing and a plurality of coil windings disposed within the coilhousing.
 4. The blood pump of claim 3, wherein the coil housing isdisposed within a pump housing and surrounds the driven magnet assembly.5. The blood pump of claim 1, wherein the driven magnet assemblycomprises a permanent magnet disposed within a magnet cover.
 6. A bloodpump, comprising: a pump housing; an impeller disposed within the pumphousing; a drive shaft disposed within the pump housing, coupled to theimpeller and configured to rotate with the impeller; a driven magnetassembly disposed within the pump housing and coupled to at least one ofthe drive shaft and the impeller; and a proximal bearing assembly,wherein a proximal end of the drive shaft is rotatably retained by theproximal bearing assembly; the proximal bearing assembly comprising: afirst bearing portion comprising a distal-facing bearing surface; asecond bearing portion comprising a proximal-facing bearing surface; anda third bearing portion comprising a radially-facing bearing surface,wherein the first, second, and third bearing portions are configured tobe coupled together to create a chamber configured to retain theproximal end of the drive shaft.
 7. The blood pump of claim 6, whereinthe driven magnet assembly is coupled to the drive shaft proximal theimpeller.
 8. The blood pump of claim 6, wherein the driven magnetassembly comprises a permanent magnet disposed within a magnet cover.